A Phase 2/3 interventional study of Dietary Supplement containing resistant starch and Placebo Starch in COVID-19, sponsored by Yale University. Terminated at 2 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by Yale University · Phase 2/3, Interventional, and Treatment
This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.
The COVID-19 pandemic has caused a substantial strain on the healthcare system, with at least 14% of infected patients requiring hospitalization. Identifying ways to ameliorate the progression and severity of the COVID-19 infection and preventing hospitalization is critical. Patients suffering from COVID-19 have been shown to have a significant inflammatory response resembling that of cytokine release syndrome, and it is this inflammatory phase that is thought to drive fatality.
To this end, a multi-center randomized clinical trial to determine the efficacy of resistant starch in reducing the need for hospitalization for COVID-19 positive patients will be studied. This study will enroll 1500 non-hospitalized COVID-19 positive individuals who are being monitored in the outpatient setting. Patients will be randomized to either a dietary supplement containing resistant starch or a placebo for 14 days. Our primary outcome is the rate of hospitalization for COVID-19 related complications. Secondary outcomes will look at time to recovery and symptom severity scores.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 226 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive a dietary supplement containing resistant starch and be instructed to take 2 tablespoons (\~20 grams) twice daily for 14 days. Initially subjects will take 2 tablespoons once daily for the first three days prior to increasing to 2 tablespoons twice daily.
Drug: Dietary Supplement containing resistant starch
Subjects will receive a placebo starch, consisting of non resistant starch and be instructed to take 2 tablespoons (\~ 20 grams) twice daily for 14 days. Initially subjects will take 2 tablespoons once daily for the first three days.
Dietary Supplement: Placebo Starch
Two tablespoons (\~ 20 grams) to be taken twice daily for 14 days (start with 2 tablespoons once daily for three days, followed by twice daily on days 4 through 14)
Also known as: Resistant Starch
Two tablespoons (\~ 20 grams) to be taken twice daily for 14 days (start with 2 tablespoons once daily for three days, followed by twice daily on days 4 through 14)
Also known as: Non Resistant Starch
Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3)
Hospitalization for a COVID-19 related admission during the first month of follow up. Death prior to hospitalization thought to be secondary to COVID-19 will also be defined as an event.
Time frame: One month from the start of treatment
Time to Clinical Recovery (TTCR) (Phase 2)
Time to clinical recovery will be defined by a return to normal body temperature (97-99 degrees F) as reported by the patient, and resolution of major presenting symptoms (myalgia, cough, shortness of breath, and GI symptoms) maintained for 72 hours. Patients will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via a pre-specified questionnaire. Patients will be followed from the start of treatment to the end of follow-up at 4 months.
Time frame: One month from the start of treatment, up to 4 months
Peak Symptom Severity Score (Phase 2)
This score will be evaluated using a subjective self-reporting questionnaire around 8 symptoms, which include: shortness of breath at rest or exertion, fatigue, myalgia/muscle aces, fever, cough, headache, GI symptoms, inability to taste or smell. Subjects will rate each of their symptoms on an ordinal scale as follows: absent (0), mild (1), moderate (2), or severe (3). These symptom ratings will be added to define the symptom severity score with a possible score range of 0-24 points. Subjects will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via this pre-specified questionnaire. Patients will be followed from the start of treatment to the end of follow-up at 4 months. "Peak" was added to the outcome title (to correctly identify the measure) when results were entered.
Time frame: One month from the start of treatment, up to 4 months
| Milestone | Placebo Supplement | Resistant Starch Supplement |
|---|---|---|
| Started | 113 | 113 |
| Completed | 71 | 68 |
| Not completed | 42 | 45 |
| Withdrew: Withdrawal by subject | 32 | 33 |
| Withdrew: Lost to follow-up | 10 | 12 |
Hospitalization for a COVID-19 related admission during the first month of follow up. Death prior to hospitalization thought to be secondary to COVID-19 will also be defined as an event.
| Participants | Control | Intervention |
|---|---|---|
| Count of Participant Hospitalization for a COVID-19 Related Complication (Phase 3) | 2 | 2 |
Time to clinical recovery will be defined by a return to normal body temperature (97-99 degrees F) as reported by the patient, and resolution of major presenting symptoms (myalgia, cough, shortness of breath, and GI symptoms) maintained for 72 hours. Patients will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via a pre-specified questionnaire. Patients will be followed from the start of treatment to the end of follow-up at 4 months.
| days | Resistant Starch Supplement | Placebo Supplement |
|---|---|---|
| Time to Clinical Recovery (TTCR) (Phase 2) | 12 (0 to 42) | 8 (0 to 42) |
This score will be evaluated using a subjective self-reporting questionnaire around 8 symptoms, which include: shortness of breath at rest or exertion, fatigue, myalgia/muscle aces, fever, cough, headache, GI symptoms, inability to taste or smell. Subjects will rate each of their symptoms on an ordinal scale as follows: absent (0), mild (1), moderate (2), or severe (3). These symptom ratings will be added to define the symptom severity score with a possible score range of 0-24 points. Subjects will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via this pre-specified questionnaire. Patients will be followed from the start of treatment to the end of follow-up at 4 months. "Peak" was added to the outcome title (to correctly identify the measure) when results were entered.
| score on a scale | Resistant Starch Supplement | Placebo Supplement |
|---|---|---|
| Peak Symptom Severity Score (Phase 2) | 6 (0 to 16) | 5 (0 to 17) |
Collected over Up to 1 month after completion of treatment course. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Supplement | 0/113 (0%) | 0/113 (0%) | 24/113 (21.2%) |
| Resistant Starch Supplement | 0/113 (0%) | 0/113 (0%) | 35/113 (31%) |
| Event | Placebo Supplement | Resistant Starch Supplement |
|---|---|---|
| GasGastrointestinal disorders | 24/113 | 35/113 |
| Age, Continuous(years) | Placebo Supplement | Resistant Starch Supplement | Total |
|---|---|---|---|
| Median | 45 (19 to 77) | 45 (19 to 79) | 45 (19 to 79) |
| Sex: Female, Male(Participants) | Placebo Supplement | Resistant Starch Supplement | Total |
|---|---|---|---|
| Female | 65 | 70 | 135 |
| Male | 48 | 43 | 91 |
| Race/Ethnicity, Customized(Participants) | Placebo Supplement | Resistant Starch Supplement | Total |
|---|---|---|---|
| Black | 92 | 94 | 186 |
| White | 15 | 13 | 28 |
| Unknown | 6 | 6 | 12 |
| Region of Enrollment(participants) | Placebo Supplement | Resistant Starch Supplement | Total |
|---|---|---|---|
| United States | 113 | 113 | 226 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified data underlying results for publication are planned to be made available after publication.
Supporting information: Study protocol, Sap
This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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